A Phase I Study of Gemcitabine, Capecitabine and ZD6474 (ZACTIMA) in Patients With Advanced Solid Tumors With an Expanded Cohort of Patients With Biliary or Pancreatic Malignancies.

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Aurora,
Colorado80045

Purpose:

Zactima will be used in this study to determine the highest dose that can be given safely as
well as the side effects of Zactima when in combination with two FDA approved drugs;
gemcitabine and capecitabine. This combination will be given to patients with advanced solid
tumors. Once the highest dose of the combination has been determined, additional patients
with biliary cancers (cholangiocarcinomas and gallbladder cancer) and locally advanced or
metastatic pancreatic cancer will be treated at the highest determined dose for further
studies.

Study summary:

This phase I study will access a novel regimen using a multi-targeted anti-angiogenic agent
which targets the tyrosine kinase of vascular endothelial growth factor (VEGF) receptor 2
and epidermal growth factor receptor (EGFR) in combination with cytotoxic agents:
gemcitabine and capecitabine. The rationale is based on observations that there is an
additive / synergistic effect when cytotoxic agents are combined with angiogenesis
inhibitors. There is also evidence that EGFR mediated signaling pathways are potent
stimulators of VEGF production. Also the concept of dual targeting of tumor and endothelial
cells may provide more encouraging results.

Criteria:

Inclusion Criteria:
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (measure of your
ability to perform everyday tasks)
- Life expectancy of at least three months
Blood samples and other testing may apply for further testing of eligibility.
Exclusion Criteria:
- Uncontrolled illness (for example, current infections or heart conditions)
- Abnormal laboratory tests (such as blood or urine testing)
- Pregnant or breastfeeding women
Further exclusion criteria may apply.

NCT ID:

NCT00551096

Primary Contact:

Principal InvestigatorStephen Leong, MDUniversity of Colorado, Denver

Backup Contact:

N/A

Location Contact:

Aurora, Colorado 80045United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

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